Testosterone
- Product NDC
- 0591-3524
- 11-digit product format
- 005913524
- Labeler code
- 0591
- Product ID
- 0591-3524_2e95e259-83f9-4189-885b-0d119c3a3885
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA091073
- Marketing category
- ANDA
- Marketing start
- 2017-10-12
- Substance
- TESTOSTERONE
- Active strength
- 50 mg/5g
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Testosterone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 50 mg/5g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1597129 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-3524-26 | Testosterone | 5 g in 1 TUBE | GEL | 5 | | 19 |
| 0591-3524-30 | Testosterone | 30 in 1 CARTON | GEL | 30 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3524 | TESTOSTERONE GEL [ACTAVIS PHARMA, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20231021_e18b4495-c5a3-4a7f-9636-179320784381.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-3524-26 | 00591352426 | 5 g in 1 TUBE | 5 g | | | | | Historical |
| 0591-3524-30 | 00591352430 | 30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26) | 30 tube | 2017-10-12 | 0000-00-00 | No | No | Current |